Senior Medical Writer (With Italian)

TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing, and functional service (FSP) solutions.

About The Role

The Medical Writer / Technical Reviewer will be responsible for ensuring the scientific accuracy, data quality, referencing, appropriate style, and correct branding of scientific/medical assets for the sponsor globally. The role involves working in an international and cross-functional environment, following global and local guidelines, and collaborating closely with internal and external stakeholders to ensure the highest quality of sponsor assets and gathering data on asset quality and agency performance.

Key Responsibilities

1. Perform data/reference quality checks of scientific/medical assets, ensuring all content is scientifically accurate and supported by Reference Documents.
2. Review content for non-compliance with local regulatory guidelines.
3. Perform actions in the Review and Approval platform (Veeva Vault), such as reference tagging or claims object creation.
4. Verify anchors/links to references supporting the scientific/medical assets.
5. Identify assets that may require pre-alignment with internal stakeholders.
6. Flag claims that may be difficult to substantiate or do not follow regulatory/internal guidelines.
7. Track asset quality data for internal and external reporting.

Qualifications

1. Experienced Medical Writer or Medical Content Reviewer (3-5 years), with a scientific background and degree (PharmD, MD, PhD, or Masters), with at least 3 years of experience producing or reviewing content for the Pharma/Biotech industry.
2. Excellent medical writing skills.
3. Strong attention to detail, accuracy, and the ability to manage multiple detailed activities in a results-oriented, fast-paced environment.
4. Good communication, coordination, and time management skills.
5. Fluent in oral and written English AND Italian.
6. Ability to work within a team or across multiple teams (including remotely) and independently.
7. Values teamwork, collaboration, diversity, inclusion, and innovation.
8. Prior experience in content creation for Biotech/Pharma is advantageous.
9. Experience with therapeutic areas such as Metabolism, Cardiovascular Diseases, Chronic Kidney Disease, Respiratory, Inflammation is advantageous.
10. Experience with the Pharmaceutical Content Review process and/or Veeva Vault is advantageous.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. Join a team that values collaboration, innovation, and making a difference in patients' lives.

About Us

Founded over 27 years ago in Lund, Sweden, TFS HealthScience is a full-service, global CRO with over 800 professionals operating in more than 40 countries. We deliver tailored clinical research services across key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making and help us attract and retain talented individuals. We foster a culture of innovation, collaboration, and mutual respect, aiming to make a meaningful difference in healthcare.